{
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{
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"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
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},
{
"NDCCode": "70692-792-00",
"PackageDescription": "48 BOX in 1 CARTON (70692-792-00) / 1500 CAPSULE, LIQUID FILLED in 1 BOX",
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"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Simethicone",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"StartMarketingDate": "20210810",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Strive Pharmaceuticals Inc.",
"SubstanceName": "DIMETHICONE",
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"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "10-AUG-21"
},
{
"NDCCode": "65498-286-00",
"PackageDescription": "57934 TABLET, FILM COATED in 1 DRUM (65498-286-00) ",
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"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate",
"DosageFormName": "TABLET, FILM COATED",
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"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "500; 2; 15; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-08-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "16-MAR-20"
},
{
"NDCCode": "65498-344-00",
"PackageDescription": "58067 TABLET, FILM COATED in 1 DRUM (65498-344-00) ",
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"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
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"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "500; 15; 30",
"StrengthUnit": "mg/1; mg/1; mg/1",
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"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "16-MAR-20"
},
{
"NDCCode": "65498-363-00",
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"NDC11Code": "65498-0363-00",
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"NonProprietaryName": "Pseudoephedrine Hydrochloride",
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"LabelerName": "Kenvue Canada Inc.",
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"StrengthUnit": "mg/1",
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"StartMarketingDatePackage": "07-APR-21"
},
{
"NDCCode": "65498-446-00",
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"ProductNDC": "65498-446",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen And Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
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"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "500; 15",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-08-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "03-MAY-24"
},
{
"NDCCode": "65498-453-00",
"PackageDescription": "66667 TABLET, FILM COATED in 1 DRUM (65498-453-00) ",
"NDC11Code": "65498-0453-00",
"ProductNDC": "65498-453",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20220505",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "McNeil Consumer Healthcare, a division of Johnson & Johnson",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "05-MAY-22"
},
{
"NDCCode": "65498-551-00",
"PackageDescription": "48278 TABLET, FILM COATED in 1 DRUM (65498-551-00) ",
"NDC11Code": "65498-0551-00",
"ProductNDC": "65498-551",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20240503",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "500; 2; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-08-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "03-MAY-24"
},
{
"NDCCode": "65498-753-00",
"PackageDescription": "74050 TABLET, CHEWABLE in 1 DRUM (65498-753-00) ",
"NDC11Code": "65498-0753-00",
"ProductNDC": "65498-753",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-08-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-FEB-22"
},
{
"NDCCode": "65498-790-00",
"PackageDescription": "296350 TABLET, CHEWABLE in 1 DRUM (65498-790-00) ",
"NDC11Code": "65498-0790-00",
"ProductNDC": "65498-790",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-08-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-FEB-22"
},
{
"NDCCode": "65498-791-00",
"PackageDescription": "74050 TABLET, CHEWABLE in 1 DRUM (65498-791-00) ",
"NDC11Code": "65498-0791-00",
"ProductNDC": "65498-791",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-08-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-FEB-22"
},
{
"NDCCode": "54868-3655-0",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (54868-3655-0)",
"NDC11Code": "54868-3655-00",
"ProductNDC": "54868-3655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vyvanse",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100304",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021977",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Vyvanse, a prodrug of the CNS stimulant dextroamphetamine, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1): 1 Children: Efficacy was established in two trials in 6-12 year olds with ADHD. (14), 2 Adolescents: Efficacy was established in one trial in 13-17 year olds with ADHD (14), 3 Adults: Efficacy was established in two trials in adults with ADHD. (14).",
"Description": "Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide."
},
{
"NDCCode": "54868-5827-0",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (54868-5827-0)",
"NDC11Code": "54868-5827-00",
"ProductNDC": "54868-5827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vyvanse",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080711",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021977",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Vyvanse, a prodrug of the CNS stimulant dextroamphetamine, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1): 1 Children: Efficacy was established in two trials in 6-12 year olds with ADHD. (14), 2 Adolescents: Efficacy was established in one trial in 13-17 year olds with ADHD (14), 3 Adults: Efficacy was established in two trials in adults with ADHD. (14).",
"Description": "Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide."
},
{
"NDCCode": "54868-5916-0",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (54868-5916-0)",
"NDC11Code": "54868-5916-00",
"ProductNDC": "54868-5916",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vyvanse",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080711",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021977",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Vyvanse, a prodrug of the CNS stimulant dextroamphetamine, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1): 1 Children: Efficacy was established in two trials in 6-12 year olds with ADHD. (14), 2 Adolescents: Efficacy was established in one trial in 13-17 year olds with ADHD (14), 3 Adults: Efficacy was established in two trials in adults with ADHD. (14).",
"Description": "Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide."
},
{
"NDCCode": "54868-6009-0",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (54868-6009-0)",
"NDC11Code": "54868-6009-00",
"ProductNDC": "54868-6009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vyvanse",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021977",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Vyvanse, a prodrug of the CNS stimulant dextroamphetamine, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1): 1 Children: Efficacy was established in two trials in 6-12 year olds with ADHD. (14), 2 Adolescents: Efficacy was established in one trial in 13-17 year olds with ADHD (14), 3 Adults: Efficacy was established in two trials in adults with ADHD. (14).",
"Description": "Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide."
},
{
"NDCCode": "65498-108-25",
"PackageDescription": "40 mg in 1 CONTAINER (65498-108-25) ",
"NDC11Code": "65498-0108-25",
"ProductNDC": "65498-108",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Paracetamol",
"DosageFormName": "TABLET, COATED",
"StartMarketingDate": "20250501",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/500mg",
"Status": "Unfinished",
"LastUpdate": "2025-05-02",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-MAY-25"
},
{
"NDCCode": "65498-232-01",
"PackageDescription": "67000 TABLET, CHEWABLE in 1 DRUM (65498-232-01) ",
"NDC11Code": "65498-0232-01",
"ProductNDC": "65498-232",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"StartMarketingDate": "20160601",
"EndMarketingDate": "20270730",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"StartMarketingDatePackage": "01-JUN-16",
"EndMarketingDatePackage": "30-JUL-27"
},
{
"NDCCode": "65498-475-50",
"PackageDescription": "18 mg in 1 DRUM (65498-475-50) ",
"NDC11Code": "65498-0475-50",
"ProductNDC": "65498-475",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Paracetamol",
"DosageFormName": "TABLET, COATED",
"StartMarketingDate": "20250430",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kenvue Canada Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/325mg",
"Status": "Unfinished",
"LastUpdate": "2025-05-01",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "30-APR-25"
},
{
"NDCCode": "0054-0370-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-0370-25) ",
"NDC11Code": "00054-0370-25",
"ProductNDC": "0054-0370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202827",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6."
},
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"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6."
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"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6."
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"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6."
},
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"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6."
},
{
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"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
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"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6."
},
{
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"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
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"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze."
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
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"DEASchedule": "CII",
"Status": "Active",
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"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze."
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"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze."
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"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze."
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"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze."
}
]
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<IndicationAndUsage>Vyvanse, a prodrug of the CNS stimulant dextroamphetamine, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1): 1 Children: Efficacy was established in two trials in 6-12 year olds with ADHD. (14), 2 Adolescents: Efficacy was established in one trial in 13-17 year olds with ADHD (14), 3 Adults: Efficacy was established in two trials in adults with ADHD. (14).</IndicationAndUsage>
<Description>Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.</Description>
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<IndicationAndUsage>Vyvanse, a prodrug of the CNS stimulant dextroamphetamine, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1): 1 Children: Efficacy was established in two trials in 6-12 year olds with ADHD. (14), 2 Adolescents: Efficacy was established in one trial in 13-17 year olds with ADHD (14), 3 Adults: Efficacy was established in two trials in adults with ADHD. (14).</IndicationAndUsage>
<Description>Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.</Description>
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<IndicationAndUsage>Vyvanse, a prodrug of the CNS stimulant dextroamphetamine, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1): 1 Children: Efficacy was established in two trials in 6-12 year olds with ADHD. (14), 2 Adolescents: Efficacy was established in one trial in 13-17 year olds with ADHD (14), 3 Adults: Efficacy was established in two trials in adults with ADHD. (14).</IndicationAndUsage>
<Description>Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.</Description>
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<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
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<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
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<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vyvanse, a prodrug of the CNS stimulant dextroamphetamine, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1): 1 Children: Efficacy was established in two trials in 6-12 year olds with ADHD. (14), 2 Adolescents: Efficacy was established in one trial in 13-17 year olds with ADHD (14), 3 Adults: Efficacy was established in two trials in adults with ADHD. (14).</IndicationAndUsage>
<Description>Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with NRP104) contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Green #3, and FD&C Red #40. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.</Description>
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<NDC>
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<NonProprietaryName>Paracetamol</NonProprietaryName>
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<LabelerName>Kenvue Canada Inc.</LabelerName>
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<LastUpdate>2025-05-02</LastUpdate>
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<StartMarketingDatePackage>01-MAY-25</StartMarketingDatePackage>
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<LastUpdate>2025-11-14</LastUpdate>
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<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Kenvue Canada Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
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<Status>Unfinished</Status>
<LastUpdate>2025-05-01</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-APR-25</StartMarketingDatePackage>
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<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
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<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6.</Description>
</NDC>
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<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6.</Description>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6.</Description>
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<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6.</Description>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6.</Description>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6.</Description>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]., 3 Limitations of Use:, 4 The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]., 5 Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, are capsules for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: ammonium hydroxide, calcium phosphate, gelatin, iron oxide black, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac glaze, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg capsule also contains FD&C red #40. The 20 mg capsule also contains yellow iron oxide. The 30 mg capsule also contains FD&C yellow #6. The 40 mg capsule also contains FD&C blue #1 and FD&C green #3. The 50 mg and 60 mg capsules also contain D&C red #28 and FD&C blue #1. The 70 mg capsule also contains D&C red #28, FD&C blue #1, and FD&C yellow #6.</Description>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.</Description>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.</Description>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.</Description>
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<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.</Description>
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<NDC>
<NDCCode>0378-6858-77</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6858-77) </PackageDescription>
<NDC11Code>00378-6858-77</NDC11Code>
<ProductNDC>0378-6858</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202835</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: : 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C17H33N3O7S2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules:. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, or 40.5 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.</Description>
</NDC>
</NDCList>